News about "National Medical Products Administration (NMPA)"

Accro Bioscience's AC-101 Enters NMPA Rare Disease Development Pilot Program

Accro Bioscience’s AC-101, a novel selective RIPK2 inhibitor, enters the NMPA CDE Caring Plan-Extension pilot program for rare disease drug development.

National Medical Products Administration (NMPA) | 14/09/2026 | By News Bureau |  107

Milestone's Etripamil Nasal Spray Wins China NMPA Approval for PSVT

Milestone Pharmaceuticals’ etripamil nasal spray receives China NMPA approval for PSVT, triggering a USD 2 million payment and expanding access in Greater China.

National Medical Products Administration (NMPA) | 05/09/2026 | By News Bureau

Mabwell Secures FDA Clearance for 9MW5211 Clinical Trial Application

Mabwell receives US Food and Drug Administration (FDA) IND clearance for 9MW5211, a novel antibody therapy being developed for Inflammatory Bowel Disease (IBD) clinical studies.

National Medical Products Administration (NMPA) | 11/05/2026 | By News Bureau |  202

China Approves Jaypirca for Relapsed CLL and SLL Patients

Jaypirca (pirtobrutinib) by Innovent Biologics has been approved in China for the treatment of adults with relapsed or refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL). The BTK inhibitor is designed to overcome resistance associated with prior covalent BTK therapies.

National Medical Products Administration (NMPA) | 02/03/2026 | By News Bureau |  200

China Approves Trelegy Ellipta for Uncontrolled Asthma

China has approved Trelegy Ellipta for adults with uncontrolled asthma, extending its use beyond COPD and making it the only single-inhaler triple therapy for both conditions in the country.

National Medical Products Administration (NMPA) | 27/01/2026 | By News Bureau |  325

Innovent's PECONDLE Becomes China's First Approved IL-23p19 Antibody

Innovent has received NMPA approval for PECONDLE (picankibart injection), marking China’s first IL-23p19 monoclonal antibody to be cleared for treating moderate-to-severe plaque psoriasis in adults eligible for systemic therapy.

National Medical Products Administration (NMPA) | 02/12/2025 | By Dineshwori |  563

Zydus Lifesciences Receives USFDA Tentative Nod for Generic Multiple Sclerosis Drug

Zydus Lifesciences has received tentative approval from the United States Food and Drug Administration (USFDA) for Diroximel Fumarate delayed-release capsules, 231 mg, a generic version of Vumerity delayed-release capsules of the same strength.

National Medical Products Administration (NMPA) | 13/11/2025 | By Dineshwori |  484

Glenmark Secures China's Approval For RYALTRIS

Glenmark Pharmaceuticals has received regulatory approval in China for RYALTRIS. Combining olopatadine hydrochloride and mometasone furoate, it offers dual-action relief from nasal symptoms, further strengthening Glenmark’s position as a global leader in respiratory innovation.

National Medical Products Administration (NMPA) | 11/11/2025 | By Dineshwori |  694

Akeso's Ivonescimab Wins 4th Breakthrough Therapy Nod in China for TNBC

Akeso has secured its fourth Breakthrough Therapy Designation (BTD) in China for Ivonescimab, targeting first-line treatment of triple-negative breast cancer (TNBC). The ongoing Phase III HARMONi-BC1 trial is assessing its safety and efficacy in this hard-to-treat cancer type.

National Medical Products Administration (NMPA) | 03/11/2025 | By Dineshwori |  284

Anbenitamab Set to Lead as First Bispecific mAb in China's HER2+ Gastric Cancer Market: GlobalData

China’s NMPA has accepted Alphamab Oncology’s NDA for KN026 (Anbenitamab), which could become the first bispecific mAb for HER2-positive gastric and GEJ cancer, according to GlobalData.

National Medical Products Administration (NMPA) | 25/09/2025 | By Dineshwori |  448